2018 Speakers
Click on a speaker’s name for their full bio. Speaker information will be updated as received.
Justin T. Baker, M.D., Ph.D.
Assistant Professor
Director of Functional Neuroimaging & Bioinformatics
Schizophrenia and Bipolar Disorder Program, Scientific Director, Institute for Technology in Psychiatry
McLean Hospital. Harvard Medical School
Henry Chen, MBA
Principal Offering Manager
IBM Watson for Drug Discovery
Cartier Esham, Ph.D.
Executive Vice President for Emerging Companies
Biotechnology Innovation Companies (BIO)
Baruch Fischhoff, Ph.D.
Howard Heinz University Professor
Department of Engineering and Public Policy
Institute for Politics and Strategy
Carnegie Mellon University
Peter Honig, M.D., M.P.H.
Senior Vice President and Head
Worldwide Safety and Regulatory
Pfizer
Jake LaPorte, Ph.D.
Head of Digital Development
Global Drug Development
Portfolio Strategy & Innovation
Novartis
Shanthi Ganesham, Ph.D.
Head of Oncology
North American Regulatory Affairs
Novartis Pharmaceuticals
Michael Holmes, Ph.D.
Vice President, Research
Sangamo Therapeutics
Ed Margerrison, Ph.D.
Director
Office of Science and Engineering
Federal Drug Administration
Mark B. McClellan, M.D, Ph.D.
Director and Robert J. Margolis, MD Professor of Business
Medicine and Policy, Duke University
Senior Health Policy Advisor
Dell Medical School, The University of Texas at Austin
Mehul Mehta, Ph.D.
Director
Division of Clinical Pharmacology I Office of Clinical Pharmacology
Federal Drug Administration
Sarah Pope Miksinski, Ph.D.
Astra Zeneca
Richard Moscicki, M.D.
Chief Medical Officer
Executive Vice President
Pharmaceutical Research and Manufacturers of America (PhRMA)
Gary Noel, M.D.
Pediatric Infectious Disease
Chair Janssen’s Pediatric Advisory Committee
Drug Development Center of Excellence
Johnson and Johnson
Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA, CDER,OPS
Salomon Stavchansky, Ph.D.
ICD2 Conference Scientific Chair
Professor of Pharmaceutics
UT Austin College of Pharmacy
Robert Temple, M.D. – Appearance Canceled 2/8/18
Deputy Center Director for Clinical Science
Acting Deputy Director of the Office of Drug Evaluation I (ODE-I)
Center for Drug Evaluation and Research
Federal Drug Administration
Henrietta Ukwu, MD, FACP, FRAPS
Senior Vice President
Head of Global Quality & Global Regulatory Affairs
Otsuka Pharmaceutical
Wendy Wilson-Lee, Ph.D.
Acting Branch Chief
Office of New Drug Products
Center for Drug Evaluation and Research
Federal Drug Administration
Celia Witten, M.D., Ph.D.
Deputy Director
Center for Biologics Evaluation and Research
Food and Drug Administration
Janet Woodcock, M.D.
Director
FDA, CDER
Andrew Wright
Vice President
Digital Medicine
Otsuka Pharmaceutical Companies
Moderators
Arthur A. Ciociola, Ph.D., F.A.C.G.
Vice President, Head of Global Regulatory Affairs
Alcon Research, Ltd.
John M. Engel, Esq.
Founder and Managing Member
EngelNovitt, PLLC
Charles Hoiberg, Ph.D.
Executive Director
Pfizer, Inc
Kay Holcombe
Retired
Former Senior Vice-President Science Policy
Biotechnology Industry Association (BIO)
Pravin Jadhav, Ph.D, MPH, MPharm
Senior Director
Corporate Projects, R&D Innovation
Otsuka Pharmaceutical Development and Commercialization (OPDC)
Kenneth I. Kaitin, Ph.D.
Professor and Director • Tufts Center for the Study of Drug Development
Tufts University
Andrea Masciale
Vice President
Regulatory Policy and Global Analytics
Johnson & Johnson Worldwide Government Affairs & Policy
Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
OTS, CDER, FDA
Sarah Pope Miksinski, Ph.D.
Astra Zeneca
Nicholas Pelliccione, Ph.D.
Vice President, Regulatory Affairs
Turing Pharmaceuticals
Lisa A. Shipley, Ph.D.
Vice President & Global Head
Pharmacokinetics,
Pharmacodynamics & Drug Metabolism
Merck & Co., Inc.
Gretchen Trout
Head, North America Policy & FDA Liaison
Regulatory Affairs
Novartis Pharmaceuticals Corp.
Paula Rinaldi
North American Head of DRA
Novartis Pharmaceuticals
Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA, CDER,OPS
Gerald J. Yakatan, Ph.D.
Founder & Chairman
IriSys, Inc.
